Bimekizumab efficacy in high-impact areas for patients with moderate to severe plaque psoriasis: pooled results through two years from the be sure and be radiant phase 3 trials

Background High levels of complete clearance of plaque psoriasis in high-impact areas such as the scalp, nails, palms and soles have been reported in patients (pts) after 1 year (yr) of bimekizumab (BKZ) treatment. [1] Objectives Assess scalp, nail and palmoplantar outcomes over 2 yrs from two BKZ phase 3 trials in moderate to severe plaque psoriasis. Methods Data were pooled over 2 yrs from the BE RADIANT phase 3b trial ( NCT03536884 ), including Yr1 of its ongoing open-label extension (OLE), and the 1-yr BE SURE phase 3 trial ( NCT03412747 ) with the ongoing OLE, BE BRIGHT ( NCT03598790 ). [2,3] Pts included were randomised at baseline to BKZ 320 mg every 4 weeks (wks; Q4W) and then continued to receive BKZ Q4W or switched to BKZ every 8 wks (Q8W) at Wk16, and received the same dose on entering the OLE (Q4W/Q4W/Q4W or Q4W/Q8W/Q8W). Regional involvement was analysed using scalp Investigator’s Global Assessment (scalp IGA; 5-point scale [0–4]), modified Nail Psoriasis Severity Index (mNAPSI; total fingernail score, 0–130 scale) and palmoplantar (pp)-IGA (5-point scale [0–4]). We report proportions of pts who achieved complete regional clearance (scalp IGA 0, mNAPSI 0, pp-IGA 0) through Yr2 (OLE Wk48) among pts with moderate to severe regional involvement at baseline (scalp IGA ≥3, mNAPSI >10, pp-IGA ≥3). Missing data were imputed as non-response (NRI). Results Of pts who entered the OLEs from BE SURE and BE RADIANT, 303 and 323 received BKZ Q4W/Q4W/Q4W and Q4W/Q8W/Q8W, respectively. Of these, 209 (69.0%) and 241 (74.6%) had baseline scalp IGA ≥3; 43 (14.2%) and 44 (13.6%) had pp-IGA ≥3; 100 (33.0%) and 111 (34.4%) had mNAPSI >10. Among pts with baseline scalp IGA ≥3, 78.0% and 81.7% treated with BKZ Q4W/Q4W/Q4W and Q4W/Q8W/Q8W achieved scalp IGA 0 at Wk16, respectively; 80.4% and 79.3% achieved scalp IGA 0 at Yr2 (OLE Wk48) ( Table 1 ). Of pts with baseline pp-IGA ≥3, 60.5% and 81.8% treated with BKZ Q4W/Q4W/Q4W and Q4W/Q8W/Q8W achieved pp-IGA 0 at Wk16, respectively; 83.7% and 81.8% achieved pp-IGA 0 at Yr2 ( Table 1 ). Of pts with baseline mNAPSI >10, 51.0% and 58.6% treated with BKZ Q4W/Q4W/Q4W and Q4W/Q8W/Q8W achieved mNAPSI 0 at Wk32, respectively; 40.0% and 59.5% achieved mNAPSI 0 at Yr2 ( Table 1 ). Conclusion A high percentage of BKZ-treated pts achieved complete clearance of scalp and palmoplantar psoriasis at Wk16, which was sustained over 2 yrs. Complete nail clearance continued to increase through Yr1, reflecting the longer timescale required for nail growth, and was generally sustained through Yr2. Proportions of pts achieving complete nail, scalp and palmoplantar clearance were generally comparable between BKZ Q4W/Q4W/Q4W and Q4W/Q8W/Q8W dosing regimens. Reference [1]Merola JF. Presented at EADV 2021; 2. Reich K. N Eng J Med 2021;385(2):142–52; 3. Warren RB. N Eng J Med 2021;385(2):130–41. Table 1. Complete regional clearance of scalp, nail, or palmoplantar psoriasis over 2 years (NRI) BKZ 320 mg Q4W/Q4W/Q4W n (%) BKZ 320 mg Q4W/Q8W/Q8W n (%) Scalp IGA ≥3 at baseline N=209 N=241 Scalp IGA 0 at Wk16 163 (78.0) 197 (81.7) Scalp IGA 0 at Yr1 a 186 (89.0) 206 (85.5) Scalp IGA 0 at Yr2 b 168 (80.4) 191 (79.3) mNAPSI >10 at baseline N=100 N=111 mNAPSI 0 at Wk32 c 51 (51.0) 65 (58.6) mNAPSI 0 at Yr1 a 54 (54.0) 79 (71.2) mNAPSI 0 at Yr2 b 40 (40.0) 66 (59.5) pp-IGA ≥3 at baseline N=43 N=44 pp-IGA 0 at Wk16 26 (60.5) 36 (81.8) pp-IGA 0 at Yr1 a 35 (81.4) 41 (93.2) pp-IGA 0 at Yr2 b 36 (83.7) 36 (81.8) a Wk48 of treatment; b OLE Wk48: BE RADIANT Wk96 and BE SURE/BE BRIGHT Wk104 of total treatment; c mNAPSI response initially reported at Wk32 due to the longer timescale required for nail growth vs skin clearance. Pts included had regional involvement at baseline and entered the OLE without switching maintenance dose. Treatment groups refer to BKZ dosing schedules in Wks: 0–16/16–48/OLE entry. BKZ: bimekizumab; IGA: Investigator’s Global Assessment; mNAPSI: modified Nail Psoriasis Severity Index; NRI: non-responder imputation; OLE: open-label extension; pp: palmoplantar; pts: patients; Q4W: every 4 wks; Q8W: every 8 wks; wk: week; yr: year. Acknowledgements Funded by UCB Pharma. Medical writing support by Costello Medical. Disclosure of Interests Joseph F. Merola Consultant of: Consultant and/or investigator for AbbVie, Amgen, Bayer, Biogen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi-Regeneron, and UCB Pharma. Principal Investigator for Dermavant, LEO Pharma, and UCB Pharma., Alice B Gottlieb Speakers bureau: Honoraria as an advisory board member, non-promotional speaker or consultant for Amgen, AnaptysBio, Avotres Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, DiCE Therapeutics, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi, Sun Pharma, UCB Pharma, and XBiotech (stock options for an RA project)., Consultant of: Honoraria as an advisory board member, non-promotional speaker or consultant for Amgen, AnaptysBio, Avotres Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, DiCE Therapeutics, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi, Sun Pharma, UCB Pharma, and XBiotech (stock options for an RA project)., Grant/research support from: Research/educational grants from AnaptysBio, Bristol Myers Squibb, Janssen, Novartis, Ortho Dermatologics, Sun Pharma, and UCB Pharma; all funds go to the Icahn School of Medicine at Mount Sinai., Akimichi Morita Speakers bureau: Received research grants, consulting fees, and/or speaker’s fees from AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eisai, Eli Lilly, Janssen, Kyowa Hakko Kirin, LEO Pharma, Maruho, Mitsubishi Tanabe Pharma, Nichi-Iko, Nippon Kayaku, Novartis, Pfizer, Sun Pharma, Taiho Pharma, Torii Pharma, UCB Pharma, and Ushio., Consultant of: Received research grants, consulting fees, and/or speaker’s fees from AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eisai, Eli Lilly, Janssen, Kyowa Hakko Kirin, LEO Pharma, Maruho, Mitsubishi Tanabe Pharma, Nichi-Iko, Nippon Kayaku, Novartis, Pfizer, Sun Pharma, Taiho Pharma, Torii Pharma, UCB Pharma, and Ushio., Grant/research support from: Received research grants, consulting fees, and/or speaker’s fees from AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eisai, Eli Lilly, Janssen, Kyowa Hakko Kirin, LEO Pharma, Maruho, Mitsubishi Tanabe Pharma, Nichi-Iko, Nippon Kayaku, Novartis, Pfizer, Sun Pharma, Taiho Pharma, Torii Pharma, UCB Pharma, and Ushio., Jose M Carrascosa Consultant of: Participated as Principal/Senior Investigator and/or consultant and/or advisor for AbbVie, Amgen, Biogen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, LEO Pharma, Novartis, Sandoz, and UCB Pharma., Boni Elewski Consultant of: Consultant (honoraria) from Arcutis, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, LEO Pharma, Menlo, Novartis, Pfizer, Sun Pharma, UCB Pharma, Valeant, and Verrica., Grant/research support from: Received research support as funding to Case Western Reserve University from AbbVie, AnaptysBio, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Incyte, LEO Pharma, Menlo, Merck, Novartis, Pfizer, Regeneron, Sun Pharma, Valeant, and Vanda., Nicola Tilt Shareholder of: Stockholder of GSK and UCB Pharma., Employee of: Employee of UCB Pharma., Susanne Wiegratz Shareholder of: Shareholder of UCB Pharma., Employee of: Employee of UCB Pharma., Krista Wixted Shareholder of: Shareholder of UCB Pharma., Employee of: Employee of UCB Pharma., Ulrich Mrowietz Consultant of: Served as advisor and/or clinical study investigator for, and/or received honoraria and/or grants from AbbVie, Almirall, Aristea, Boehringer Ingelheim, Celgene, Dr. Reddy’s Laboratories, Eli Lilly, Foamix, Formycon, Forward Pharma, Janssen, LEO Pharma, Medac, Novartis, Phi-Stone, Pierre Fabre, Sanofi, and UCB Pharma., Grant/research support from: Served as advisor and/or clinical study investigator for, and/or received honoraria and/or grants from AbbVie, Almirall, Aristea, Boehringer Ingelheim, Celgene, Dr. Reddy’s Laboratories, Eli Lilly, Foamix, Formycon, Forward Pharma, Janssen, LEO Pharma, Medac, Novartis, Phi-Stone, Pierre Fabre, Sanofi, and UCB Pharma.